April 14 Clinical Research Compensation Fund launches

The law's provisions will take effect on April 14. On that day, a Clinical Trials Compensation Fund will be established at the Patient Ombudsman. This is an innovative solution expected by patients and the clinical research industry. The Ombudsman will also maintain a publicly accessible list of patient organizations.

The law increases the attractiveness of conducting clinical trials in Poland and ensures a high level of care for the rights and interests of participants in these trials. The solutions introduced include:

• Establishment of the Supreme Bioethics Commission,
• A new fee system for conducting scientific and ethical assessments of a research registration application,
• separate rules for publicly funded research (e.g., by the Medical Research Agency),
• Increase transparency in the rules for financing healthcare services provided to patients participating in clinical trials.

An important novelty is the provision of patient representatives to participate in the ethical review of designed clinical trials.

To simplify the procedures involved in starting clinical trials, the application for trial authorization is submitted through the European Union Portal (CTIS), and only once, regardless of the number of countries in which the trial is to be conducted. This publicly accessible website provides access to detailed information on all clinical trials starting in Europe, which is particularly valuable for those interested in participating (see https://euclinicaltrials.eu/search-for-clinical-trials/?lang=pl).

The Clinical Trials Compensation Fund, which is being created by the law, will provide a fast-track compensation path for those who have suffered harm (injury) due to participation in a clinical trial. From its funds, the Ombudsman will award a monetary benefit of up to PLN 200,000. In the event of the death of a trial participant, each of his or her next of kin will in turn be able to receive up to PLN 100 thousand. The fund will cover damages that occurred in connection with participation in a clinical trial initiated after the date the law enters into force.

- I am very pleased with the great confidence that has once again been placed in our institution. Thanks to the law, we will gain yet another tool that will allow us to effectively help patients. The Immunization Compensation Fund, which has been in operation for over a year, has proven to be the right direction. Clinical trials are another important area where victims will be able to count on quick and concrete financial support," emphasized Patient Ombudsman Bartlomiej Chmielowiec.

After the new regulations come into force, we will publish on our website a model application for the benefit and practical guidelines related to filing the application and claiming compensation. We will also indicate the bank account number to which companies applying for a clinical trial permit will pay the fee to the Fund.

The law imposes another important duty on the Ombudsman - to maintain a list of patient organizations. This refers to associations and foundations whose statutory objectives include the protection of patients' rights. The list will be maintained in electronic form and available on our website. Entry on the list will be at the request of the organization. Importantly, organizations included in the list will be entitled to submit candidacies for participation in the work of the Supreme Bioethics Committee and the Appeals Committee for the Clinical Research Compensation Fund. The list itself will also be a source of up-to-date information for all patients and other interested individuals and institutions.

Along with the new regulation, a ban on charging participants in medical experiments will also go into effect.

Source: MPC